BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 3212288 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12500
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE OPERATED AS INTENDED DURING THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - DRIVE CABLE WRAP-UP/TORQUE. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, WHILE TRYING TO ACTIVATE THE DEVICE BLADE, THE WIRE OF THE DEVICE BEGAN TO TANGLE, NOT ALLOWING TISSUE TO BE CUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312972 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK MT217795

    Patients

    Seq Age Sex Outcome Treatment
    1